Cleared Traditional

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 (K884598) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884598 · Shimadzu Precision Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
168d
Days
Class 2
Risk

K884598 is an FDA 510(k) clearance for the SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on April 20, 1989 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shimadzu Precision Instruments, Inc. devices

Submission Details

510(k) Number K884598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1988
Decision Date April 20, 1989
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 72
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K884598.
FLUROSPOT H VERSION 2
K914525 · Siemens Medical Solutions USA, Inc. · Nov 1991
LASER BEAM LOCALIZER FOR SIREMOBIL 4
K912380 · Siemens Medical Solutions USA, Inc. · Jul 1991
DIGIFORMER HR DFP-50A
K901405 · Toshiba America Medical Systems, In.C · May 1990
UNIVERSAL ABC CONTROLER
K883580 · Philips Medical Systems (Cleveland), Inc. · Jan 1989
LP LATERAL FLUORO POSITIONER (B5077A)
K872061 · General Electric Co. · Jun 1987
SCX SYSTEM
K862120 · General Electric Co. · Jun 1986